NDC 0378-9126

FENTANYL

Fentanyl

FENTANYL is a Transdermal Patch in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Fentanyl.

Product ID0378-9126_5cbb788c-026f-496d-b801-f63f6b53a99b
NDC0378-9126
Product TypeHuman Prescription Drug
Proprietary NameFENTANYL
Generic NameFentanyl
Dosage FormPatch
Route of AdministrationTRANSDERMAL
Marketing Start Date2015-02-26
Marketing CategoryANDA / ANDA
Application NumberANDA076258
Labeler NameMylan Pharmaceuticals Inc.
Substance NameFENTANYL
Active Ingredient Strength63 ug/h
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-9126-98

5 POUCH in 1 CARTON (0378-9126-98) > 1 PATCH in 1 POUCH (0378-9126-16) > 72 h in 1 PATCH
Marketing Start Date2015-02-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-9126-98 [00378912698]

FENTANYL PATCH
Marketing CategoryANDA
Application NumberANDA076258
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-02-26

NDC 0378-9126-16 [00378912616]

FENTANYL PATCH
Marketing CategoryANDA
Application NumberANDA076258
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-02-26

Drug Details

Active Ingredients

IngredientStrength
FENTANYL62.5 ug/h

OpenFDA Data

SPL SET ID:2a2238e9-4b5d-c56d-8663-dd354ff9ae0c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1603501
  • 197696
  • 245136
  • 245135
  • 245134
  • 1603498
  • 577057
  • 1603495
  • Pharmacological Class

    • Full Opioid Agonists [MoA]
    • Opioid Agonist [EPC]

    NDC Crossover Matching brand name "FENTANYL" or generic name "Fentanyl"

    NDCBrand NameGeneric Name
    0378-9119FENTANYLFENTANYL
    0378-9121FENTANYLFENTANYL
    0378-9122FENTANYLFENTANYL
    0378-9123FENTANYLFENTANYL
    0378-9124FENTANYLFENTANYL
    0378-9125FENTANYLFENTANYL
    0378-9126FENTANYLFENTANYL
    0378-9127FENTANYLFENTANYL
    0591-3198FentanylFentanyl
    0591-3212FentanylFentanyl
    0591-3213FentanylFentanyl
    0591-3214FentanylFentanyl
    0781-7240FentanylFentanyl
    0781-7241FentanylFentanyl
    0781-7242FentanylFentanyl
    0781-7243FentanylFentanyl
    0781-7244FentanylFentanyl
    68258-3023FentanylFentanyl
    68258-3040FentanylFentanyl
    68258-3024FentanylFentanyl
    68258-3025FentanylFentanyl
    71335-0376FENTANYLFENTANYL
    71335-0649FentanylFentanyl
    71335-0556FentanylFentanyl
    71335-0604FentanylFentanyl
    35356-633FENTANYLFENTANYL
    35356-635FentanylFentanyl
    35356-062FentanylFentanyl
    35356-632FENTANYLFENTANYL
    35356-634FENTANYLFENTANYL
    49884-763FentanylFentanyl
    49884-762FentanylFentanyl
    49884-764FentanylFentanyl
    49884-761FentanylFentanyl
    49999-834FentanylFentanyl
    49999-832FentanylFentanyl
    49999-833FentanylFentanyl
    49999-831FentanylFentanyl
    51862-317FentanylFentanyl
    51862-314FentanylFentanyl
    51862-316FentanylFentanyl
    51862-315FentanylFentanyl
    52959-585FentanylFentanyl
    52959-658FentanylFentanyl
    55700-402FENTANYLFENTANYL
    60505-7081FENTANYLFENTANYL
    60505-7086FENTANYLFENTANYL
    60505-7082FENTANYLFENTANYL
    60505-7009FENTANYLFENTANYL
    60505-7014FENTANYLFENTANYL

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